Manufacturers

Who manufactures our lasers

Modestic™ lasers are built in Shanghai and Zhengzhou. We publish each manufacturer’s full legal name, its address and its authorised representative in the European Union, taken from the device documents and from the manufacturer’s own EUDAMED record. Every one of those details can be checked in the public registers.

Checked against the device documents and EUDAMED:

Modestic visiting a production floor: assembly benches and parts racks

Division of roles

Who answers for what

The manufacturer answers for the device before the law. Modestic answers for what you receive in Poland. The clinic answers for how the device is run day to day.

Manufacturer

Design and conformity

  • Design, construction and manufacture of the device
  • Technical documentation and conformity assessment involving a notified body
  • Instructions for use, including who may operate the device
  • Authorised representative in the European Union

Modestic

Exclusive distributor in Poland

  • The device with instructions for use in Polish
  • Training included in the price of the laser
  • 24-month warranty and repairs within 7 working days at most
  • Our own service workshop, taking devices from across the European Union
  • Parts and service available for 5 years from purchase

Clinic

Day-to-day work

  • Working in line with the instructions for use
  • Optical radiation risk assessment
  • An inspection every 12 months or every 250 000 pulses, whichever comes first
  • Reporting a serious incident to the manufacturer and to the President of the Office (URPL)

Manufacturer data

From the device documents and EUDAMED

The manufacturer’s name, address and authorised representative are transcribed from the device documents and from the manufacturer’s own EUDAMED record. The SRN beside each manufacturer links straight to that record.

The manufacturer’s address comes from its own EUDAMED record; the founding year and the site area are as published on the manufacturer’s website.

The device class, the transitional route and the notified body for each model are published in one place. Regulatory status of the models →

Modestic

What you get in Poland

You buy from the exclusive distributor of these devices in Poland. Beyond the laser itself, that means:

Instructions for use in PolishThe device arrives with instructions for use in Polish. That document decides who may operate the laser, and at which settings.
Training in the priceTraining on operating the device and on treatment protocols is included in the price of the laser.
24-month warrantyIt covers every component apart from consumable parts.
Service across the UnionOur own workshop takes devices from across the European Union, with courier pickup. Repairs within 7 working days at most, and a replacement device at no extra charge while a major repair runs.
Parts for 5 yearsWe keep parts and service available for 5 years from purchase.
Device documentsWe make the device documents available to customers at purchase.

Check it yourself

Where to check

You can look a manufacturer up in EUDAMED by name, and a notified body number in NANDO. The status of each model is gathered on our regulatory page.

  • Regulatory status of the models: device class, transitional route and notified body for Edge, Pico and Ultra.
  • EUDAMED: the EU database of economic operators; both manufacturers’ records are linked above, beside their SRN.
  • NANDO: the European Commission’s database of notified bodies.

Questions

Common questions about the manufacturers

Are these Chinese lasers?

Yes. Modestic™ Edge and Modestic™ Pico are manufactured by Shanghai Apolo Medical Technology Co., Ltd. in Shanghai, and Modestic™ Ultra by Zhengzhou PZ Laser Slim Technology Co., Ltd. in Zhengzhou. Whether a laser may lawfully be used in Poland is not decided by the country of manufacture but by the documents: the manufacturer’s registration in EUDAMED, the notified body in NANDO, and instructions for use in Polish stating who may operate the device.

Who is the manufacturer under the medical device rules?

The company named as manufacturer on the nameplate and in the instructions for use: Shanghai Apolo Medical Technology Co., Ltd. for Modestic™ Edge and Modestic™ Pico, and Zhengzhou PZ Laser Slim Technology Co., Ltd. for Modestic™ Ultra. The manufacturer answers for the conformity assessment, the technical documentation and the instructions for use. Modestic is the exclusive distributor of these devices in Poland, and Modestic™ is their trade name.

Can I buy such a laser directly from the manufacturer?

No. Modestic is the exclusive distributor of these devices on the Polish market. Buying from us, you get the device with instructions for use in Polish, a 24-month warranty, service with courier pickup across the European Union, and training in the price of the laser.

Why are the lasers called Modestic if someone else makes them?

Modestic™ is the trade name the devices are sold under. The manufacturer and its own model designation are given on the nameplate and in the instructions for use of every unit, and this page reproduces them in full.

What about service and parts if a manufacturer changes its range?

We keep parts and service available for 5 years from purchase. Inspections, calibration and repairs are carried out by our own workshop, which takes devices from across the European Union.

A question about a manufacturer or a device document?

Write to us →